Laparoscopic Scalpel and Method for Use

ABSTRACT

A laparoscopic scalpel includes a shaft and a recess disposed in a surface of the shaft proximal to a distal end of the shaft. A blade is attached to the shaft. The blade includes a cutting edge having a portion exposed by the recess and oriented outwardly from the recess. A proximal end of the portion of the cutting edge exposed by the recess is disposed further from the surface than is a distal end of the portion of the cutting edge exposed by the recess.

CROSS-RELATED APPLICATIONS

The present application claims priority from and is a continuation fromU.S. patent application Ser. No. 14/923,136, filed Oct. 26, 2015, whichclaims priority to U.S. patent application Ser. No. 14/053,331, filedOct. 14, 2013, now U.S. Pat. No. 9,168,058, which claims priority fromand is a continuation from U.S. patent application Ser. No. 13/035,598,filed Feb. 25, 2011, which is now U.S. Pat. No. 8,585,725, all of whichare herein incorporated by reference in their entireties.

Field of the Invention

The present invention relates generally to a laparoscopic surgicaldevice. More particularly, the present invention relates to alaparoscopic scalpel that facilitates enlargement of a laparoscopicincision through the peritoneum, fascia, and abdominal wall muscles forextraction of solid organs or other specimens, and/or introduction ofintraluminal staplers or other devices.

BACKGROUND OF THE INVENTION

Laparoscopic surgery, also known as “minimally invasive” surgery, is amethod for performing surgery via one or more small incisions typicallyon the order of about 1 cm across. It is known that laparoscopic surgeryoffers many benefits to patients and the healthcare system including,for example, less pain, shorter hospital stay, quicker return to normalactivity and to work, and better cosmetic results. These benefits makethe health care system more efficient; thus laparoscopic techniques arein high demand.

Laparoscopic surgery has revolutionized patient care in the last 20years. In many cases, minimally invasive approaches have become thestandard care, even for specialties such as gynecology, urology, kidneytransplant, and foregut surgery. In 2010, there were 2.8 millionminimally invasive procedures performed in the United States alone,representing an increase of about 2.6% from 2009. However, theseprocedures include only about 38% of colectomies and 25% hysterectomiesbeing performed in a minimally invasive fashion. Furthermore, theseprocedures do not include the usage of the current inventive device inprocedures such as adrenalectomy, gastrectomy, donor and pathologicalnephrectomies, prostates, and liver resections. Therefore, the number ofminimally invasive procedures is expected to continue to rise astechnology expands.

Furthermore, with the advent of ‘robotic’ surgery more and moretechniques are being created. In the past, many surgeons abstained fromlaparoscopic or robotic techniques because it was felt to not offer anadvantage if solid organs required extraction. For example, if a surgeonwas doing a colon resection, it was not uncommon for surgeons to performthe operation in an ‘open’ fashion or quickly convert from laparoscopicto open knowing that they were going to require an open incision toextract the solid organ in question.

As more intra-abdominal surgery is being offered with minimally invasivetechniques, surgeons need to have the ability to extract a specimen, forexample a solid organ, either whole or morcellated. To facilitate theremoval of larger solid organs such as, for example, kidneys, adrenals,the uterus, colon, small bowel, gallbladder, and tumors, a surgeon hasto create a sufficiently wide extraction site on the peritoneal surfaceof the abdominal wall. However, in order to preserve the integrity ofthe minimally invasive operation, surgeons strive to remove the specimenthrough the smallest possible skin incision. Therefore, a problem mayarise when a specimen needing to be removed is larger than any of thelaparoscopic incisions.

Currently, there is no reliable ‘sharp’ option available for lengtheninga laparoscopic incision. For example, if an organ requires extraction,the skin is cut with a scalpel; however, the fascia, muscle, andperitoneum are all bluntly ‘ripped’ and spread apart by the surgeon'sfingers or a blunt instrument to allow for extraction of the organ. Thisblunt method, while adequate, is imprecise, takes increased time toexecute, and leads to a considerable amount of tissue trauma, causingincreased postoperative pain. In addition, this blunt method leads tothe instant loss of the pneumoperitoneum, which is gas normally sealedwithin the body cavity. Such loss of the pneumoperitoneum may result ina massive expulsion of carbon dioxide gas and aerosolized body fluidwhen the organ is removed under pressure of the pneumoperitoneum. Suchexpulsion may expose the surgeons and operating room technologists to aninfectious disease hazard and therefore is a safety issue.

Although not widely used, a “fascia scalpel” manufactured by LiNAMedical in Glostrup, Denmark, is designed to be inserted next to aspecimen bag which is being pulled up against the abdominal wall. Thiscreates problems as the bag will tend to surround and engulf the LiNAscalpel, and the specimen bag can be cut which can lead to loss ofintegrity of the bag, loss of containment of the specimen, and potentialdissemination of contaminated fluid, for example, an infected appendix,or cancerous cells, for example, a malignant tumor. Thus, the scalpel isdesigned for cutting more superficially on the abdominal wall or themore dorsal part of the skin and is not designed for the more ventralpart of the abdominal wall. The LiNA fascia scalpel is designed for usewith smaller solid organs like the appendix and/or gallbladder. The LiNAfascia scalpel is not designed to be placed through a trocar, nor doesthe LiNA scalpel have a blunt distal end to protect tissue fromunintended damage. Additionally, the LiNA fascia scalpel does not enablesurgeons to use the instrument under visualization nor does it allowsurgeons to work without releasing the pneumoperitoneum.

Further issues exist with using a traditional surgical scalpel toenlarge a laparoscopic incision. For example, when using a regularsurgical scalpel attached to a standard or longer handle, it is possiblethat the scalpel blade may be dislodged from the handle by the abdominalwall tissue and/or the rubber housing of existing trocars if the scalpelis introduced inside the trocar. In addition, standard cutting with ascalpel is not protected and surrounding tissues can be unintentionallyinjured. Further, a traditional surgical scalpel or a LiNA fasciascalpel can slip and fall freely into the abdomen creating an enterotomy(bowel injury) and thus have potentially devastating consequences.

A need exists for a laparoscopic scalpel that can precisely enlarge alaparoscopic incision without compromising the pneumoperitoneum. Such adevice would safely, quickly, and efficiently incise the peritoneum,fascia, and abdominal wall muscles to extract solid organs or introduceintraluminal staplers or other devices. Such a device would allow forextraction of larger specimens, which allows for wider applicabilityacross multiple specialties including, but not limited to urology,gynecology, general surgery, bariatric surgery, endocrine surgery,colorectal surgery, liver surgery, and thoracoscopic surgery of thechest.

SUMMARY OF THE INVENTION

one aspect of the present invention, a laparoscopic scalpel includes ashaft and a recess disposed in a surface of the shaft proximal to adistal end of the shaft. A blade is attached to the shaft. The bladeincludes a cutting edge having a portion exposed by the recess andoriented outwardly from the recess. A proximal end of the portion of thecutting edge exposed by the recess is disposed further from the surfacethan is a distal end of the portion of the cutting edge exposed by therecess.

In another aspect of the present invention, a laparoscopic scalpelincludes a shaft and a recess disposed in a surface of the shaftproximal to a distal end of the shaft. A blade is attached to the shaft.The blade includes a cutting edge having a portion exposed by the recessand oriented outwardly from the recess. A proximal end of the portion ofthe cutting edge exposed by the recess is disposed further from thesurface than is a distal end of the portion of the cutting edge exposedby the recess. A handle is disposed on a proximal end of the shaft andextends from the shaft along a plane that is generally parallel to thecutting edge.

In a further aspect of the present invention, a method for using alaparoscopic scalpel is presented. The laparoscopic scalpel includes ashaft, a recess disposed in a surface of the shaft proximal to a distalend of the shaft, and a blade attached to the shaft. The blade includesa cutting edge having a portion exposed by the recess and orientedoutwardly from the recess. The portion of the cutting edge exposed bythe recess is disposed at a non-zero angle relative to the surface. Theshaft is adapted to be inserted through a trocar into a patient whilegenerally maintaining the patient's pneumoperitoneum. The methodincludes the steps of inserting a distal end of the shaft into a trocardisposed within a laparoscopic incision, translating the trocarproximally relative to the shaft to expose one or more of the fascia,muscle, and peritoneum to the cutting edge while generally maintainingthe patient's pneumoperitoneum, and cutting the one or more of thefascia, muscle, and peritoneum or other dorsal part of the abdominalwall with the cutting edge to enlarge the laparoscopic incision withoutcompromise of the patient's pneumoperitoneum.

The foregoing and other features and advantages are defined by theappended claims. The following detailed description of exemplaryembodiments, read in conjunction with the accompanying drawings ismerely illustrative rather than limiting, the scope being defined by theappended claims and equivalents thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying figures, like elements are identified by likereference numerals among the several preferred embodiments of thepresent invention.

FIG. 1 illustrates an isometric view of an embodiment of a laparoscopicscalpel.

FIG. 2 illustrates a side elevation of the laparoscopic scalpel of FIG.1.

FIG. 3 illustrates a side elevation of another embodiment of alaparoscopic scalpel.

FIG. 4 illustrates a side elevation of a further embodiment of alaparoscopic scalpel disposed in relation to a proximal end of a trocar.

FIG. 5 illustrates an isometric view of yet another embodiment of alaparoscopic scalpel.

FIGS. 6A-6F illustrate cross-sectional views of embodiments of alaparoscopic scalpel taken generally along the lines 6-6 of FIG. 2.

FIG. 7 illustrates a cross-sectional view of a trocar disposed throughlayers of tissue.

FIG. 8 illustrates a cross-sectional elevational view of insertion of anembodiment of the laparoscopic scalpel of the current invention into abody cavity via a trocar.

FIG. 9 illustrates a cross-sectional isometric view of insertion ofanother embodiment of the laparoscopic scalpel of the current inventioninto a body cavity via a trocar.

FIG. 10 illustrates rotationally orienting the laparoscopic scalpel ofthe current invention following insertion thereof into a trocar.

FIG. 11 illustrates lateral and proximal manipulation of thelaparoscopic scalpel of the current invention relative to an incision.

FIG. 12 illustrates an embodiment for enlarging a laparoscopic incisionthat includes a longitudinally reciprocating motion of the cutting edge.

FIG. 13 illustrates an embodiment for enlarging a laparoscopic incisionthat includes a transverse slicing motion of the cutting edge.

DETAILED DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention areapparent from the following detailed description of exemplaryembodiments, read in conjunction with the accompanying drawings. Thedetailed description and drawings are merely illustrative of theinvention rather than limiting, the scope of the invention being definedby the appended claims and equivalents thereof.

Language indicative of a relative geometric relationship betweencomponents includes use of the terms “proximal” and “distal” herein. Inthis context, “proximal” refers to an end of a component nearest to themedical practitioner during use and “distal” refers to the end of thecomponent furthest from the medical practitioner during use.

Referring to FIGS. 1-3, in one embodiment, a laparoscopic scalpel 100includes a shaft 102 having a proximal end 104, a distal end 106 and asurface 108. A recess 110 is disposed in the surface 108 of the shaft102 proximal to the distal end 106 of the shaft 102. In one embodiment,the distal end 106 has a blunt end surface 112. A blade 114 is attachedto the shaft 102 and includes a cutting edge 116. In one embodiment, thecutting edge 116 may include serrations 117, as illustrated in FIG. 4.The blade 114 may be attached to the shaft by any method as known in theart, including by way of example and not limitation, being overmolded bythe material of the shaft, attached to the shaft via a fastener, andbeing constructed integrally from the same material as the shaft.

The blade is disposed relative to the shaft such that a portion of thecutting edge 116 is exposed by the recess 110 and is oriented outwardrelative to the recess 110. The portion of the cutting edge 116 exposedby the recess 110 includes a proximal end 118 and a distal end 120. Inone embodiment, the cutting edge 116 is linear between the proximal anddistal ends 118, 120. In other embodiments, the cutting edge 116 may beconvex, concave, or a combination of convex, concave and/or linearbetween the proximal and distal ends 118, 120. As will be more fullydescribed hereinbelow, in one embodiment, the proximal end 118 may bedisposed further from the surface 108 than is the distal end 120. Inthis embodiment, if the cutting edge 116 is linear, there results anon-zero angle 122 (See FIG. 2) between the cutting edge 116 and aregion of the surface 108 replaced by the recess 110.

Because no portion of the blade 114 extends beyond the surface 108, theblade 114 may be completely shielded by any tube or shield that can befit over the shaft 102. Such protection provides safety againstunintentional application of the cutting edge 116 to tissue.Configuration of the recess 110 proximal to the distal end 106 of theshaft 102 provides a region of the surface 108 between the blade 114 andthe distal end 106 of the shaft 102. Such configuration may providefurther safety against an end of the blade 114 extending to near or pastthe distal end 106.

In another embodiment, the surface 108 near the proximal end 104 of theshaft 102 may include a rubberized or otherwise textured and/orcompressible material 105, as illustrated by the cross-hatched region inFIG. 3. In another embodiment, the proximal end 104 of the shaft 102 mayinclude a tapered or enlarged portion 103, as illustrated in FIG. 4. Ina further embodiment, the proximal end 104 of the shaft 102 includes theenlarged portion 103 including the rubberized or otherwise texturedand/or compressible material 105, as illustrated by the cross-hatchedregion in FIG. 5. The enlarged portion 103 and/or the material 105 mayfacilitate anchoring or docking a trocar or sheath 200 (See FIG. 4) tothe proximal end 104, such as for example, when the trocar 200 is slidproximally relative to the shaft 102 as illustrated by arrow 156 in FIG.4. Such docking may help to stabilize the trocar or sheath 200 whileoperating the laparoscopic scalpel 100.

Referring to FIGS. 1-5, in another embodiment, an edge guide 124 may bedisposed longitudinally along the surface 108 generally aligned with thecutting edge 116. The edge guide 124 provides an indication of thedirection that the cutting edge 116 is facing when the cutting edge 116is not visible to the surgeon, for example, when the laparoscopicscalpel 100 is inserted into a trocar or other sleeve 200 (See FIGS.7-13). The edge guide 124 may be a visible line on the surface 108,and/or may include a tactile component such as a raised rib or groovealong the surface 108. The addition of a tactile component may behelpful to a surgeon in the event that the surface 108 becomes obscuredby fluid or other material.

In a further embodiment of the laparoscopic scalpel 100, a handle 12.6is disposed on the proximal end 104 of the shaft 102. As will be morefully explained hereinbelow, the handle 126 is oriented transversely tothe shaft 102, as illustrated in FIGS. 1, 2, 4, and 5. In oneembodiment, the handle 126 extends transversely from the shaft 102 in adirection that is generally normal to the edge guide 124. In anotherembodiment, the handle 126 is disposed on the proximal end 104 of theshaft 102 and extends transversely from the shaft 102 along a plane thatis generally parallel to the cutting edge 116. In a further embodiment,the handle 126 is detachably disposed on the proximal end 104 of theshaft 102. Such detachable attachment may be via a press fit, a snapfit, a threaded attachment, a bayonet attachment, matching of aparticular shaped rib and groove, and the like.

Transverse extension of the handle 126 relative to the shaft 102 mayprovide a medical professional with additional leverage or an improvedangle for grasping the handle 126. Such additional leverage or improvedgrasping angle may facilitate easier manipulation of the blade 114disposed proximate the distal end 106 of the shaft 102 opposite thehandle 126. Transverse extension of the handle 126 also provides asafety feature as will be further described hereinbelow.

In one embodiment, the handle 126 may further include finger grips 128disposed thereon to facilitate an improved grip on the handle 126 by amedical professional. In yet another embodiment, instead of or inaddition to the edge guide 124 that is disposed longitudinally along thesurface 108, an edge guide 130 may be disposed on an edge of the handle126 in general alignment with the cutting edge 116, as illustrated inFIGS. 1 and 3-5. Similar to the edge guide 124, the edge guide 130 maybe a visible line and/or may include a tactile component such as araised rib or groove.

Referring to FIGS. 6A-6F, the shaft 102 of the laparoscopic scalpel 100may have any cross-sectional shape disposed in any orientation relativeto the handle 126 as desired. Further, the shaft 102 may include anycross-sectional shape in regions outside of the recess 110 combined withany cross-sectional within the bounds of the recess 110. For example,referring to FIG. 6A, the shaft 102 may have a generally roundcross-sectional shape outside of the recess 110 as indicated by thegenerally round surface 108, and may have a generally elliptical shape132 within the bounds of the recess 110. Referring to FIG. 6B, forexample, the shaft 102 may have a generally semi-circular shape 134within the bounds of the recess 110. In other embodiments, the shaft mayhave an elliptical or oval shape 136 that has a long axis thereofaligned with the blade 114, as illustrated in FIG. 6C. Alternatively,the shaft 102 may have an elliptical or oval shape 138 having a shortaxis thereof aligned with the blade 114, as illustrated in FIG. 6D.

The shaft 102 may have other cross-sectional shapes and orientations,including without limitation, any closed curvilinear shape such asgenerally round, elliptical, or oval, any regular polygonal shape, andany irregular polygonal shape. For example, referring to FIG. 6E, theshaft 102 is illustrated as having a regular octagonal shape 140 inregions outside of the recess 110. Within the recess 110, the shaft isillustrated as having a half-regular octagonal shape 142. In anotherexample, referring to FIG. 6F, the shaft 102 has an irregular polygonalshape including seven sides of uneven length 144 in regions outside therecess 110, yet has the half-regular octagonal shape 142 within therecess 110.

In another embodiment, the laparoscopic scalpel 100 may includeregularly spaced distance markings 146 disposed along the surfacethereof, as illustrated in FIGS. 1-5. As will be described more fullyhereinbelow, the distance markings indicate a depth of insertion of theshaft 102 when inserted into a trocar or other sleeve 200 (See FIGS.7-13). The distance markings 146 may be visible lines on the surface108, and/or may include a tactile component such as raised ribs orgrooves along the surface 108. Similar to the edge guides 124, 130, theaddition of a tactile component to the distance markings 146 may behelpful to a surgeon in the event that the surface 108 becomes obscuredby fluid or other material.

Any of the various embodiments of the laparoscopic scalpel describedhereinabove with regard to FIGS. 1-6F may be used to enlarge alaparoscopic incision without losing a patient's pneumoperitoneum. Forexample, referring to FIG. 7, a trocar or sealing sheath 200 isillustrated inserted via an incision 202 through the various layers oftissue into a body cavity 204. The trocar 200 includes a seal (forexample, reference numeral 158 illustrated in FIG. 4) through whichother surgical tools may be passed without disturbing the seal. Thus,the interior of the trocar 200 may be exposed to a patient'spneumoperitoneum upon insertion of the trocar 200 as illustrated in FIG.7. However, the seal inhibits release of the patient's pneumoperitoneumfrom within the trocar 200.

The various layers of tissue present at a point of entry into the bodycavity 204 differ depending on location of the incision 202. Forexample, a typical cross-sectional profile of layers in the abdominalregion includes, for example, skin 206, subcutaneous tissue (mainly fat)207, ventral fascia 208 including superficial fascia 208 a and deepfascia 208 b, multiple layers of muscle 209, dorsal fascia 210 includingtransversalis fascia 210 a and subserous fascia 210 b, and theperitoneum 212. Of course, each of these layers may include one or moresublayers or additional layers as known in the art.

Referring to FIGS. 8 and 9, in one embodiment of a method for use of thelaparoscopic scalpel 100, the distal end 106 of the shaft 102 isinserted into the trocar or shield 200 already in place within theincision 202 as illustrated in FIG. 7. In one embodiment, as notedhereinabove with regard to FIGS. 1-5, the distance markings 146 disposedalong the surface 108 of the shaft 102 provide an indication of depth ofinsertion of the shaft 102 when inserted through the trocar 200. Whenusing an embodiment including the distance markings 146, the step ofinserting the distal end of the shaft 102 may further include insertingthe distal end of the shaft 102 into the trocar 200 to a desired depthof insertion. The desired depth of insertion may be determined by thedesired depth of the blade 114 relative to one or more of the layers oftissue 206, 207, 208 a, 208 b, 209, 210 a, 210 b, 212, or via otherdeterminations as known in the art.

As noted hereinabove with regard to FIGS. 1-5, in one embodiment, thehandle 126 extends transversely from the shaft 102 along a plane that isgenerally parallel to the cutting edge 116. In another embodiment, thehandle 126 extends transversely from the shaft 102 in a direction thatis generally normal to the edge guide 124, which may be generallyaligned with the cutting edge 116. In a further embodiment, the secondedge guide 130 disposed on an edge of the handle 126 may be in generalalignment with the cutting edge 116. Thus, the rotational orientation ofthe handle 126 is consistent with the rotational orientation of thecutting edge 116, such that following insertion of the laparoscopicscalpel 100 into the trocar 200, the cutting edge may be orientedrotationally as desired by rotationally adjusting the position of thehandle 126, as illustrated by arrows 214 in FIG. 10.

As noted hereinabove with regard to FIGS. 1-5, transverse extension ofthe handle 126 also provides a safety feature. Referring to FIGS. 8 and9, for example, should the laparoscopic scalpel 100 slip from the graspof a surgeon, the transverse extension of the handle 126 inhibits thelaparoscopic scalpel 100 from falling freely into the abdomen or bodycavity 204 and possibly creating an enterotomy (bowel injury) havingpotentially devastating consequences.

Referring to FIGS. 8 and 9, upon placement of the laparoscopic scalpel100 at the desired depth and orientation within the trocar 200, theblade 114 is not exposed to tissue but is shielded from surroundingtissue by the trocar 200. For illustration purposes, the trocar 200 inFIG. 9 has been drawn as transparent to show the position of the blade114 therein. Such shielding is an improvement over cutting with existingscalpels, which are not protected and which may thereby causeunintentional injury to tissue.

The cutting edge 116 of the blade 114 is exposed to tissue bytranslating the trocar 200 proximally relative to the shaft 102, asillustrated by arrow 216 in FIG. 11. The trocar 200 may be translated asdesired to expose one or more of the layers of tissue 206, 207, 208 a,208 b, 209, 210 a, 210 b, 212 as desired while generally maintaining thepatient's pneumoperitoneum. For example, as illustrated in FIG. 11, thetrocar 200 has been translated proximally relative to the shaft 102 toexpose the peritoneum 212, the dorsal fascia layers 210, the layers ofmuscle 209, and the ventral fascia layers 208 to the cutting edge 116 ofthe blade 114; however, the trocar 200 maintains a seal with the layerof skin 206 and the layer of subcutaneous tissue 207, therebymaintaining the patient's pneumoperitoneum.

Upon exposure of one or more of the layers of tissue 206, 207, 208 a,208 b, 209, 210 a, 210 b, 212 as desired, the next step is to radiallyenlarge a dorsal portion of the incision 202 without compromise of thepatient's pneumoperitoneum. This may be accomplished by creating apyramidal type incision 202 that is largest at the most dorsal part ofthe abdominal wall and that is smallest as it nears the skin level.

In practice, such a pyramidal type incision 202 may be achieved with thelaparoscopic scalpel 100 by application of one or more modes forcutting. In one embodiment, for example, referring to FIG. 11, thehandle 126 of the laparoscopic scalpel 100 may be maneuvered laterallyas illustrated by arrow 218 relative to the incision 202. Motion of thehandle laterally 218 causes the laparoscopic scalpel 100 and the trocar200 to pivot such that cutting edge 116 of the blade 114 moves to engagetissue in an opposite lateral direction as illustrated by arrow 222.Referring to FIG. 12, once so engaged in this embodiment, the handle 126may be translated in a proximal reciprocating fashion, as illustrated byarrow 224 relative to the trocar 200 and the incision 202. Such motionallows the one or more of the peritoneum 212, the dorsal fascia layers210, the muscle layers 209 and/or other layers as desired to be cut bymoving the cutting edge 116 of the blade 114 relative to the incision202 in a longitudinally reciprocating sawing type motion, as illustratedby arrow 226 in FIG. 12. Application of the longitudinally reciprocatingor sawing type motion 226 effectively enlarges the incision 202 in thedirection illustrated by arrow 228.

In another embodiment, the cutting edge 116 is maneuvered into cuttingengagement with tissue to be incised as described hereinabove withregard to FIG. 11. Referring to FIG. 13, in this embodiment, furthermotion of the handle laterally 218 causes the cutting edge 116 to cuttissue in a transverse slicing motion as indicated by arrow 230.Application of the cutting edge 116 in such transverse slicing motion230 effectively enlarges the incision 202 in the direction illustratedby arrow 232.

In a further embodiment, referring to FIG. 13, a medical professionalmay gain additional control over the cutting by application of acombination of proximal and lateral motion to the handle 126 asillustrated by the arrow 234. Such combined motion applies both alongitudinal sawing motion 226 and a transverse slicing motion 230 ofthe cutting edge 116 to the tissue to be cut.

Thus, lateral 218 and/or proximal 224 motion of the handle 126 allows asurgeon to manipulate the cutting edge 116 to incise one or more of thelayers of tissue 206, 207, 208 a, 208 b, 209, 210 a, 210 b, 212 asdesired to enlarge the incision 202 without compromise of a patient'spneumoperitoneum. In this context, features of various embodiments ofthe laparoscopic scalpel 100 as described hereinabove may providefurther advantage in enlarging the incision 202. For example, as notedhereinabove with regard to FIGS. 1-5, the proximal end 118 of theportion of the cutting edge 116 exposed by the recess 110 is disposedfurther from the surface 108 than is the distal end 120 of the portionof the cutting edge 116 exposed by the recess 110. In embodiments havinga linear cutting edge 116, such configuration results in the non-zeroangle 122 (See FIG. 2) between the cutting edge 116 and the surface 108.An instrument having a cutting edge generally aligned with the shaft ofthe instrument only allows for tissue to be incised at right angles tothe shaft of the instrument. However, the blade 114 including thecutting edge 116 configured having a non-zero angle 122 with the surface108 provides additional mechanical advantage to the surgeon allowing forprecise control over the length and location of cuts made by the cuttingedge 116 when manipulated via lateral motion 218, proximal motion 224,or a combination of proximal and lateral motion 234 of the handle 126.Such control facilitates precise incision of deeper tissue layers (forexample, the peritoneum 212, the dorsal fascia layers 210, the layers ofmuscle 209, and the ventral fascia layers 208) while leaving theincision 202 through the skin layer 206 and the subcutaneous tissuelayer 207 intact.

Referring to FIGS. 1-5, the recess 110 may have an unsymmetricallongitudinal shape that may provide additional mechanical advantage tothe surgeon to facilitate precise control over the cutting edge 116. Forexample, a distal end 148 of the recess 110 may be oriented at a firstangle 150 relative to the surface 108 and a proximal end 152 of therecess 110 may be oriented at a second angle 154 relative to the surface108. The first angle 150 may be larger, the same as, or smaller than thesecond angle 154. Making the first angle 150 larger than the secondangle 154, may, for example, allow the surgeon to precisely create theabove described pyramidal type incision having the largest expanse atthe most dorsal part of the abdominal wall and tapering up to a smallestexpanse as it nears the skin layer 206. The different (larger angle) atthe distal end 148 allows the action of the blade 114 to have betteraccess for tissue penetration to create the desired incision at thedeepest levels. Following enlargement of the laparoscopic incision 202,a surgeon may remove an organ or other tissue from the body cavity 204.

Existing methods for enlargement of a laparoscopic incision for removalof an organ or tissue sample are inadequate for several reasons. Forexample, because the incision 202 is bluntly spread or ripped apartusing existing methods, and such spreading requires access by asurgeon's fingers, the trocar 200 is necessarily removed from theincision 202 prior to such spreading. Although the surgeon quickly plugsthe incision 202 with a finger to preserve the pneumoperitoneum, removalof the trocar 200 causes some loss of the pneumoperitoneum, and the lossmay result in a spray of fluid from the body cavity 204.

Next, the incision 202 through the skin 206 is typically lengthened toaccommodate a second finger. Such lengthening of the incision 202 mayresult in additional loss of the pneumoperitoneum (and additional fluidexpulsion from the body cavity 204). Next, a blunt instrument or twofingers are used to spread the incision 202 by ripping it open. Inexisting methods, the surgeon frantically attempts to get the incision202 spread adequately before all gas pressure of the patient'spneumoperitoneum is lost.

Next, the trocar 200 is reinserted into the incision 202; however inexisting methods such reinsertion is difficult because there is nothingto mark the exact location of the incision 202 or to guide the trocar200 through the now raggedly enlarged incision 202, which may not followa straight path into the body cavity 204. Upon reinsertion of the trocar200, a grasping instrument may be inserted through the trocar 200 andvisually guided to grasp hold of the tissue to be removed. With thetissue so grasped, the trocar 200 may need to be removed from theincision 202 a second time if the tissue is too large to be removedthrough the trocar 200. Such removal of the trocar 200 from the incision202 may cause additional loss of the pneumoperitoneum through theraggedly enlarged incision 202. Next, the tissue is extracted via theraggedly enlarged incision 202, potentially causing further loss of thepneumoperitoneum.

Alternatively, using existing methods, some surgeons will controllablyrelease the pneumoperitoneum (equalize pressure, for example, by openinga valve 160 (See FIG. 9) on the trocar 200) prior to a first removal ofthe trocar 200 from the incision 202 prior to the spreading thereof.However, the lengthened incision through the skin 206 and/or the raggednature of the enlarged incision 202 caused by forced spreading orripping thereof makes subsequent reestablishment of a pneumoperitoneumproblematic.

In contrast to existing methods, by utilizing the apparatus and methodsdescribed hereinabove, the incision 202 may be more precisely enlargedbelow the skin layer 206. As noted hereinabove, precise enlargement alsocauses less postoperative pain, may heal faster, and provides bettercontrol over loss of the pneumoperitoneum. For example, in a first step,any embodiment of the laparoscopic scalpel 100 described hereinabovewith regard to FIGS. 1-6 is introduced into a body cavity 204 via atrocar 200 that has a seal as described hereinabove with regard to FIG.7. Next, the laparoscopic incision 202 is enlarged using any of theembodiments for enlargement of the incision described hereinabove withregard to FIGS. 8-13.

Next, a grasping instrument may be inserted through the trocar 200 to bevisually guided to grasp hold of the tissue to be removed. With thetissue so grasped, the pneumoperitoneum may be slowly and controllablyreleased by releasing the seal on the trocar 200. Such release may beaccomplished, for example, by opening the valve 160 (See FIG. 9) on thetrocar 200 to equalize pressure as known in the art. An outlet of thevalve 160 may be connected to a containment system (not shown) tocapture efflux of fluid released through the valve 160. Followingcontrolled release of the pneumoperitoneum, the tissue is extracted viathe enlarged incision 202.

If the tissue to be removed is small relative to the trocar 200, thetissue may be removed through the trocar 200. Alternatively, the trocar200 is removed from the incision 202 to allow for removal of tissuetherethrough. In this case, having an incision 202 that has not beenlengthened at the skin layer 206 and that has been cleanly incised atmore dorsal layers instead of being ripped open as in existing methodsfacilitates the maintenance of a seal between the incision 202 and thetissue being withdrawn. Next, the trocar 200 is reinserted into theincision 202 and the pneumoperitoneum may be reestablished. Aftersatisfactory inspection of the surgical field, the surgeon next closesthe enlarged incision 202.

Following enlargement of the laparoscopic incision 202, in lieu of or asa part of the process of removal of tissue from the body cavity 204, asurgeon may introduce a device into the body cavity 204. For example,the surgeon may introduce an intraluminal stapling device into thepatient after enlarging the laparoscopic incision 202. A stapling devicemay sometimes be inserted into the body cavity 204 to divide tissue orto create a connection between viscera therein. However, some types ofstaplers such as, for example, a circular stapler, are too large to fitthrough the trocar 200. In order to operate such staplerslaparoscopically, the incision 202 must be enlarged just enough to allowpassage of the stapler, but not so much that the pneumoperitoneum cannotbe preserved after the stapler is introduced. Using existing methods, asnoted hereinabove, the incision 202 is enlarged by bluntly spreading thetissue layers apart with the surgeon's fingers or a blunt instrument.Such blunt spreading is imprecise and frequently leads to irregularlyshaped holes which are more difficult to close and can result in herniaformation. The blunt dissection is also more traumatic and causes morepost-operative swelling and pain than a precise incision.

In contrast, using the apparatus and methods described hereinabove withregard to FIGS. 1-13, an enlarged incision 202 may be created having aregularly and precisely shaped hole that is easier to close. Such a holeis also easier to plug with a finger when necessary, for example uponremoval of the trocar 200 from the incision 202. Such a hole is alsoeasier to maintain a seal with objects passed therethrough, for example,the trocar 200 or a stapler, or even tissue being removed therethrough.Following enlargement of the incision 202, for example, such a hole iscreated that may allow for removal of the trocar 200 and insertion of afinger into the incision 202 with minimal loss of the pneumoperitoneum(assuming there has been no equalization of pressure prior to removal ofthe trocar 200). Subsequently, a stapler or other device may be passedthrough the incision while maintaining a seal between the device and theincision. Alternatively, the stapler or other device may be passedthrough the trocar 200.

A laparoscopic scalpel useful for the enlargement of a laparoscopicincision without loss of a patient's pneumoperitoneum is presented. Suchenlargement facilitates extraction of bigger specimens from a bodycavity. Extraction of bigger specimens allows for wider applicabilityacross multiple specialties, for example, including, but not limited tourology, gynecology, general surgery, bariatric surgery, endocrinesurgery, colo-rectal surgery, liver surgery, and thoracoscopic surgeryof the chest. Such enlargement further facilitates delivery of surgicaldevices, for example, intraluminal staplers, into the body cavity.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described hereinabove without departing from thebroad concepts disclosed therein. It is understood, therefore, that thisdisclosure is not limited to the particular embodiments disclosed, butit is intended to cover modifications that may include a combination offeatures illustrated in one or more embodiments with featuresillustrated in any other embodiments. Various modifications, equivalentprocesses, as well as numerous structures to which the presentdisclosure may be applicable will be readily apparent to those of skillin the art to which the present disclosure is directed upon review ofthe present specification. Accordingly, this description is to beconstrued as illustrative only and is presented for the purpose ofenabling those skilled in the art to make and use the laparoscopicscalpel described herein and to teach the best mode of carrying out thesame.

What is claimed is: 1.-20. (canceled)
 21. A laparoscopic scalpel,comprising: a shaft having a proximal end, a distal end, and a lengththerebetween, wherein the shaft is comprised of a first half shaft and asecond half shaft a button driver, comprising a cylindrical rod, anelevated button serving as a pushdown mechanism and a slot located atthe distal end of the cylindrical rod to accommodate a blade holder,wherein said slot creates a recess that houses the blade holder holdingthe blade in place a blade holder that is housed within the buttondriver slot and which is aligned with the length of the button driverslot a blade attached to a blade holder, wherein the blade includes acutting edge and wherein a proximal end of the portion of the cuttingedge exposed by the slot is disposed further from a straight linebetween the distal and proximal ends of the slot than is a distal end ofthe portion of the cutting edge exposed by the recess, when the blade isextended and wherein the cutting edge is completely encased in the slotand aligned with the length of the slot when the blade is retracted 22.A laparoscopic scalpel of claim 21, wherein the shaft is furthercomprised of a grip handle with two detachable halves, the first halfhandle connected to the proximal end of the first half shaft and thesecond half handle connected to the proximal end of the second halfshaft, wherein the two half handles are oriented longitudinally alongthe surface of their respective half shafts.
 23. A laparoscopic scalpelof claim 21, wherein the first half handle and the second half handleare each shaped like a patella.
 24. A laparoscopic scalpel of claim 21,wherein the first half handle and the second half handle are hollowedout.
 25. A laparoscopic scalpel of claim 21, wherein the exteriorsurfaces of the distal ends of each half shaft comprise remolding addedon to the outside surface of each half shaft.
 26. A laparoscopic scalpelof claim 21, wherein the distal ends of each half shaft are shaped likehemicycles.
 27. A laparoscopic scalpel of claim 21, wherein the interiorsurfaces of the first half shaft and the second half shaft are hollowedout and the distal ends of the first half shaft and second half shaftcomprise a specialized cavity designed to accommodate the blade holderattached to the blade.
 28. A laparoscopic scalpel of claim 21, whereinthe button driver is comprised of a cylindrical rod, a pushdownmechanism located at the proximal end of the cylindrical rod, and a slotlocated at the distal end of the cylindrical rod.
 29. A laparoscopicscalpel of claim 28, wherein the pushdown mechanism is comprised of asquare-shaped button mounted onto a spring device.
 30. A laparoscopicscalpel of claim 28, wherein the slot located at the distal end of thecylindrical rod comprises one open end and is further divided into twohalf slots.
 31. A laparoscopic scalpel of claim 28, wherein the distalends of the two half slots are shaped like hemicycles and comprisepre-drilled holes oppositely disposed and facing each other, one holelocated on the right half slot and the other hole located on the lefthalf slot.
 32. A laparoscopic scalpel of claim 21, wherein the bladeholder is comprised of two interlocking rectangular surfaces shaped likealligator clips and connected by two pins oppositely located at theproximal and distal ends of the surfaces.
 33. A laparoscopic scalpel ofclaim 21, wherein the blade is comprised of a bottom cutting edge, a topblunt edge, and an open cavity located on the medial surface of theblade whose outline matches the outline of the blade holder.
 34. Alaparoscopic scalpel of claim 22, wherein the bottom cutting edge issmooth and curved and the top blunt edge is straight and wherein theproximal end is tapered so as to fit into the slot area on the buttondriver.